The Biostatistics Shared Resource provides collaborative statistical support to investigators and research projects for Consortium members. Such support may include any or all of the following: selection of primary and secondary endpoints, study design, sample size and power calculations, randomization procedures, design of data collection instruments, design of early stopping criteria, interim monitoring, data retrieval and analysis and manuscript preparation and review. In general, this resource attempts to emphasize the importance of ongoing and continuing collaboration with biostatisticians during the entire research effort, rather than one-time consultation without appropriate context. Although the majority of the activities of this shared resource are anticipated to be related to research trials, and it is thus included under the Research Trials Office umbrella, its expertise can be utilized by any Consortium member requiring biostatistics support, regardless of whether it is related to a research trial. For example, it is expected that investigators from basic and population sciences as well as clinical sciences will utilize the resource's new expertise in genomic and proteomic microarray analysis.